CN113121713B - Pregelatinized starch and preparation method and application thereof - Google Patents
Pregelatinized starch and preparation method and application thereof Download PDFInfo
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- CN113121713B CN113121713B CN202110349796.1A CN202110349796A CN113121713B CN 113121713 B CN113121713 B CN 113121713B CN 202110349796 A CN202110349796 A CN 202110349796A CN 113121713 B CN113121713 B CN 113121713B
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08B—POLYSACCHARIDES; DERIVATIVES THEREOF
- C08B31/00—Preparation of derivatives of starch
- C08B31/02—Esters
- C08B31/04—Esters of organic acids, e.g. alkenyl-succinated starch
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
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Abstract
The invention provides pregelatinized starch, a preparation method and application thereof, wherein the preparation method comprises the following steps: adding food-grade starch into citric acid aqueous solution with mass fraction less than or equal to 0.08wt%, and performing ultrasonic treatment at 55-70deg.C for 45-90min; placing the material subjected to ultrasonic treatment in a ball mill, adding absolute ethyl alcohol at the same time, and ball milling for 60-90min; placing the ball-milled material into a charging hopper of an extruder, starting the extruder, controlling the temperature of a screw, and extruding at 55-75 ℃; cooling and drying the extruded material at 5-15 ℃, cutting by a granulator, and crushing to the required particle size range. The pregelatinized starch provided by the invention has the advantages of loose structure, uniform particles, low viscosity, good fluidity, high dissolution speed and high solubility; the preparation method has the advantages of simple process, convenient operation, controllable process, low production cost and the like.
Description
Technical Field
The invention relates to the technical field of preparation of pharmaceutical excipients, in particular to pregelatinized starch, and a preparation method and application thereof.
Background
The pregelatinized starch is a derivative of starch, and is specifically obtained by partially or completely cracking starch after being treated by a chemical method or a mechanical method, wherein the treatment process only modifies the physical property of the starch, and the original chemical structure is unchanged in the treatment process, so that the pregelatinized starch has good fluidity and compressibility, also has good lubrication effect, can be used as a lubricant for direct powder tabletting together with other pharmaceutical excipients, can be used as an adhesive for wet granulation, and can be used as an excipient for other solid preparations such as capsules.
In the prior art, a wet processing technology is generally adopted for preparing pregelatinized starch; such as heating methods, include: adding water to make starch slurry, adding a small amount of gelation auxiliary agent and surfactant, controlling rehydration or reducing viscosity during drying, heating for gelatinization, drying after gelatinization, pulverizing, and sieving. In recent years, water-soluble pregelatinized starch is prepared by a high-temperature high-pressure alcohol method, an alcohol-alkali method, a normal-pressure polyol method, an alcohol-hydrochloric acid method and the like.
However, the water-soluble starch prepared by the traditional method has poor quality and narrow application range; the water-soluble pregelatinized starch prepared by adopting a high-temperature high-pressure alcohol method, a normal-pressure polyol method and an alcohol-alkali method needs a large amount of alcohol or alkali, so that substances harmful to human bodies are easily generated, and the method has the defects of high equipment requirement, complex process, environment pollution, difficult control of product quality and the like, and especially has the problem that the pregelatinization degree is difficult to control when the water-soluble pregelatinized starch is used as a pharmaceutical auxiliary material.
Disclosure of Invention
The invention provides pregelatinized starch, a preparation method and application thereof for overcoming the difficulties and defects of the prior art, which can effectively overcome the defects of unstable product quality, poor fluidity, uncontrollable pregelatinization degree and the like in the prior production process, and can effectively improve the application performance of medicinal pregelatinized starch.
The invention adopts the following technical scheme:
a method for preparing pregelatinized starch comprising the steps of:
s1, adding food-grade starch into citric acid aqueous solution with mass fraction less than or equal to 0.08wt%, and carrying out ultrasonic treatment at 55-70 ℃ for 45-90min;
s2, placing the materials subjected to ultrasonic treatment in a ball mill, adding absolute ethyl alcohol at the same time, and ball milling for 60-90min;
s3, placing the ball-milled material into a charging hopper of an extruder, starting the extruder, controlling the temperature of a screw, and extruding at 55-75 ℃;
s4, cooling and drying the extruded material at the temperature of 5-15 ℃, and then cutting by a granulator and crushing to the required particle size range.
In the above technical scheme, in step S2, the mass of the anhydrous ethanol added is 0.05-0.1 times of the mass of the material after ultrasonic treatment.
Further, in the above technical solution, in step S2, specific conditions of the ball milling are that the ball-to-material ratio is controlled to be 2.2-2.5:1, and continuing ball milling for 50-75min after the temperature of the material is raised to be higher than 80 ℃.
In the above technical scheme, in step S1, the mass ratio of the food grade starch to the citric acid aqueous solution is 1:0.28-0.55.
Specifically, in the above technical solution, in step S1, the ultrasonic frequency of the ultrasonic treatment is 50000-900000Hz.
Specifically, in the above technical solution, in step S1, the ultrasonic time of the ultrasonic treatment is 50-75min.
In the above technical scheme, in step S3, the length-diameter ratio of the screw of the extruder is 20-22, and the rotation speed is 150-180rpm.
Still further, in the above technical scheme, the preparation method of pregelatinized starch further comprises drying the material after ultrasonic treatment to a water content of 12-15wt% under the condition of heating while stirring before adding the material into an addition funnel of an extruder.
In particular, in the above technical scheme, the food-grade starch is potato starch and/or cereal starch.
The invention also provides pregelatinized starch prepared by the preparation method.
Specifically, the pregelatinized starch prepared by the preparation method provided by the invention has the advantages of low viscosity, good fluidity, loose structure, high dissolution speed and high solubility.
In a further aspect, the invention also provides the use of the above preparation method or the above pregelatinized starch in the preparation of capsules or tablets.
Compared with the prior art, the invention has the beneficial effects that:
1. the pregelatinized starch provided by the invention is prepared by adopting a method of sequentially carrying out ultrasonic treatment in a citric acid aqueous solution and adding a small amount of absolute ethyl alcohol for ultrasonic treatment, extruding and forming by an extruder and cutting by a granulator in the preparation process, and the prepared pregelatinized starch has the advantages of loose structure, uniform particles, low viscosity, good fluidity, high dissolution speed and high solubility;
2. the preparation method of the pregelatinized starch provided by the invention has the advantages of simple process, convenient operation, controllable process, low production cost and the like, and has wide practical application prospect.
Detailed Description
The present invention will be described in further detail with reference to specific examples so as to more clearly understand the present invention by those skilled in the art.
The following examples are only illustrative of the present invention, but are not intended to limit the scope of the invention.
All other embodiments obtained by those skilled in the art without creative efforts are within the protection scope of the present invention based on the specific embodiments of the present invention.
In the examples of the present invention, all raw material components are commercially available products well known to those skilled in the art unless specified otherwise.
In the embodiments of the present invention, unless specifically indicated, all technical means used are conventional means well known to those skilled in the art.
Example 1
The embodiment of the invention provides pregelatinized starch and a preparation method thereof, and specifically comprises the following steps:
s1, adding wheat starch into a citric acid aqueous solution with the mass of 0.06wt% which is 0.45 times that of the wheat starch, and performing ultrasonic treatment for 60min at 65 ℃ by adopting ultrasonic waves with the frequency of 100000 Hz;
s2, placing the material subjected to ultrasonic treatment in a ball mill, simultaneously adding absolute ethyl alcohol with the mass being 0.08 times of that of the material subjected to ultrasonic treatment, and controlling the ball-material ratio to be 2.4:1, ball milling, and continuing ball milling for 60min after the temperature of the material is raised to be higher than 80 ℃;
s3, drying the ball-milled material to a water content of 13.5wt% under the condition of stirring and heating, then placing the material into an addition funnel of an extruder with an aspect ratio of 22, starting the extruder, adjusting the rotating speed to 160rpm, controlling the temperature of a screw, and extruding at 60 ℃;
s4, cooling and drying the extruded material at the temperature of 10 ℃, and then cutting and crushing the extruded material to the required particle size range by using a granulator.
Example 2
The embodiment of the invention provides pregelatinized starch and a preparation method thereof, and specifically comprises the following steps:
s1, adding corn starch into a citric acid aqueous solution with the mass of 0.05wt% which is 0.55 times that of the corn starch, and carrying out ultrasonic treatment for 90min at 60 ℃ by adopting ultrasonic waves with the frequency of 90000 Hz;
s2, placing the material subjected to ultrasonic treatment in a ball mill, simultaneously adding absolute ethyl alcohol with the mass being 0.1 times of that of the material subjected to ultrasonic treatment, and controlling the ball-material ratio to be 2.2:1, ball milling, and continuing ball milling for 50min after the temperature of the material is raised to be higher than 80 ℃;
s3, drying the ball-milled material to a water content of 12wt% under the condition of stirring and heating, then placing the material into a charging hopper of an extruder with an aspect ratio of 22, starting the extruder, adjusting the rotating speed to 150rpm, controlling the temperature of a screw, and extruding at 70 ℃;
s4, cooling and drying the extruded material at 15 ℃, and then cutting and crushing the extruded material to the required particle size range by using a granulator.
Example 3
The embodiment of the invention provides pregelatinized starch and a preparation method thereof, and specifically comprises the following steps:
s1, adding sweet potato starch into a citric acid aqueous solution with the mass of 0.08wt% which is 0.35 times that of the sweet potato starch, and carrying out ultrasonic treatment for 50min at 55 ℃ by adopting ultrasonic waves with the frequency of 800000 Hz;
s2, placing the material subjected to ultrasonic treatment in a ball mill, simultaneously adding absolute ethyl alcohol with the mass being 0.05 times of that of the material subjected to ultrasonic treatment, and controlling the ball-material ratio to be 2.5:1, ball milling, and continuing ball milling for 50min after the temperature of the material is raised to be higher than 80 ℃;
s3, drying the ball-milled material to a water content of 12.5wt% under the condition of stirring and heating, then placing the material into an addition funnel of an extruder with an aspect ratio of 20, starting the extruder, adjusting the rotating speed to 150rpm, controlling the temperature of a screw, and extruding at 75 ℃;
s4, cooling and drying the extruded material at the temperature of 5 ℃, and then cutting and crushing the extruded material to the required particle size range by using a granulator.
Example 4
The embodiment of the invention provides pregelatinized starch and a preparation method thereof, and specifically comprises the following steps:
s1, adding tapioca starch into a citric acid aqueous solution with the mass of 0.08wt% which is 0.30 times that of tapioca starch, and carrying out ultrasonic treatment for 45min at 55 ℃ by adopting ultrasonic waves with the frequency of 900000 Hz;
s2, placing the material subjected to ultrasonic treatment in a ball mill, simultaneously adding absolute ethyl alcohol with the mass being 0.1 times of that of the material subjected to ultrasonic treatment, and controlling the ball-material ratio to be 2.3:1, ball milling, and continuing ball milling for 60min after the temperature of the material is raised to be higher than 80 ℃;
s3, drying the ball-milled material to a water content of 12.5wt% under the condition of stirring and heating, then placing the material into an addition funnel of an extruder with an aspect ratio of 20, starting the extruder, adjusting the rotating speed to 175rpm, controlling the temperature of a screw, and extruding at 65 ℃;
s4, cooling and drying the extruded material at the temperature of 10 ℃, and then cutting and crushing the extruded material to the required particle size range by using a granulator.
Comparative example 1
The invention provides pregelatinized starch and a preparation method thereof, and specifically comprises the following steps:
s1, adding corn starch into a mass ratio of 1 which is 0.65 times of the mass of the corn starch: 5.5, in the mixed solution of absolute ethyl alcohol and purified water, controlling the ball-to-material ratio to be 2.2:1, ball milling, and continuing ball milling for 50min after the temperature of the material is raised to be higher than 80 ℃;
s2, adding citric acid with the mass being 0.0003 times of that of the corn starch into the ball-milled material, uniformly stirring, and performing ultrasonic treatment for 90min by adopting ultrasonic waves with the frequency of 90000 Hz;
s3, drying the material subjected to ultrasonic treatment under the condition of stirring and heating until the water content is 13.5wt%, then placing the material into a charging hopper of an extruder with an aspect ratio of 22, starting the extruder, adjusting the rotating speed to 150rpm, controlling the temperature of a screw, and extruding at 70 ℃;
s4, cooling and drying the extruded material at 15 ℃, and then cutting and crushing the extruded material to the required particle size range by using a granulator.
Comparative example 2
The invention provides pregelatinized starch and a preparation method thereof, and specifically comprises the following steps:
s1, adding tapioca starch into purified water with the mass being 0.30 times of that of tapioca starch, and carrying out ultrasonic treatment for 45min at 55 ℃ by adopting ultrasonic waves with the frequency of 900000 Hz;
s2, placing the material subjected to ultrasonic treatment in a ball mill, simultaneously adding absolute ethyl alcohol with the mass being 0.1 times of that of the material subjected to ultrasonic treatment, and controlling the ball-material ratio to be 2.3:1, ball milling, and continuing ball milling for 60min after the temperature of the material is raised to be higher than 80 ℃;
s3, drying the ball-milled material to a water content of 12.5wt% under the condition of stirring and heating, then placing the material into an addition funnel of an extruder with an aspect ratio of 20, starting the extruder, adjusting the rotating speed to 175rpm, controlling the temperature of a screw, and extruding at 65 ℃;
s4, cooling and drying the extruded material at the temperature of 10 ℃, and then cutting and crushing the extruded material to the required particle size range by using a granulator.
Comparative example 3
The invention provides pregelatinized starch and a preparation method thereof, and specifically comprises the following steps:
s1, adding sweet potato starch into a citric acid aqueous solution with the mass of 0.06wt% which is 0.55 times that of the sweet potato starch, and carrying out ultrasonic treatment for 50min at 55 ℃ by adopting ultrasonic waves with the frequency of 800000 Hz;
s2, placing the materials subjected to ultrasonic treatment in a ball mill, and controlling the ball-material ratio to be 2.5:1, ball milling, and continuing ball milling for 50min after the temperature of the material is raised to be higher than 80 ℃;
s3, drying the ball-milled material to a water content of 13.5wt% under the condition of stirring and heating, then placing the material into an addition funnel of an extruder with an aspect ratio of 20, starting the extruder, adjusting the rotating speed to 150rpm, controlling the temperature of a screw, and extruding at 75 ℃;
s4, cooling and drying the extruded material at the temperature of 5 ℃, and then cutting and crushing the extruded material to the required particle size range by using a granulator.
The pregelatinized starch samples prepared in examples 1 to 4 and comparative examples 1 to 3 of the present invention were tested with reference to the contents of "second edition of Chinese pharmacopoeia 2010", and specific test results are shown in table 1 below.
TABLE 1 quality test results of pregelatinized starch samples
In addition, the pregelatinized starch samples prepared in examples 1-4 and comparative examples 1-3 of the present invention were examined for their angle of repose, solubility in cold water and Carr coefficient, and the specific examination results are shown in Table 2 below.
TABLE 2 Angle of repose, solubility in Cold Water and Carr coefficient test results for pregelatinized starch samples
The comprehensive analysis of the results in tables 1-2 shows that the pregelatinized starch provided by the invention has loose structure, uniform particles, low viscosity, good fluidity, high dissolution speed and high solubility; the preparation method has the advantages of simple process, convenient operation, controllable process, low production cost and the like.
Finally, the method of the present invention is only a preferred embodiment and is not intended to limit the scope of the present invention. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (8)
1. A preparation method of pregelatinized starch is characterized in that,
the method comprises the following steps:
s1, adding food-grade starch into citric acid aqueous solution with mass fraction less than or equal to 0.08wt%, and carrying out ultrasonic treatment at 55-70 ℃ for 45-90min;
s2, placing the materials subjected to ultrasonic treatment in a ball mill, adding absolute ethyl alcohol at the same time, and ball milling for 60-90min;
s3, placing the ball-milled material into a charging hopper of an extruder, starting the extruder, controlling the temperature of a screw, and extruding at 55-75 ℃;
s4, cooling and drying the extruded material at the temperature of 5-15 ℃, and then cutting by a granulator and crushing the material to the required particle size range;
the added mass of the absolute ethyl alcohol is 0.05-0.1 times of the material after ultrasonic treatment;
the mass ratio of the food-grade starch to the citric acid aqueous solution is 1:0.28-0.55.
2. The method for preparing pregelatinized starch according to claim 1, wherein in step S2, the specific conditions of the ball milling are that the ball-to-material ratio is controlled to be 2.2-2.5:1, and continuing ball milling for 50-75min after the temperature of the material is raised to be higher than 80 ℃.
3. The method for preparing pregelatinized starch according to claim 1, wherein in step S1, the ultrasonic frequency of the ultrasonic treatment is 50000-900000Hz, and the ultrasonic time of the ultrasonic treatment is 50-75min.
4. The method for preparing pregelatinized starch according to claim 1, wherein in step S3, the length-diameter ratio of the screw of the extruder is 20-22 and the rotation speed is 150-180rpm.
5. The method for producing pregelatinized starch according to any one of claims 1 to 4, further comprising, before being fed into the hopper of the extruder, drying the sonicated material to a water content of 12 to 15wt% with stirring and heating.
6. The method of preparing pregelatinized starch according to claim 1, wherein the food-grade starch is potato starch and/or cereal starch.
7. The pregelatinized starch prepared by the method of claim 1.
8. The use of pregelatinized starch prepared by the method of claim 1 in capsules or tablets.
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH01287101A (en) * | 1988-05-13 | 1989-11-17 | Nippon Shokuhin Kako Co Ltd | Production of processed starch |
| CN102134281A (en) * | 2011-01-30 | 2011-07-27 | 广西大学 | Method for producing high-flowability pregelatinized starch |
| CN107163151A (en) * | 2017-06-12 | 2017-09-15 | 安徽紫山农业科技有限公司 | One kind prepares pregelatinized starch method with sweet potato starch |
| CN108148144A (en) * | 2016-12-02 | 2018-06-12 | 湖南尔康制药股份有限公司 | A kind of improvement of the preparation method of medicinal pregelatinized starch |
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- 2021-03-31 CN CN202110349796.1A patent/CN113121713B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH01287101A (en) * | 1988-05-13 | 1989-11-17 | Nippon Shokuhin Kako Co Ltd | Production of processed starch |
| CN102134281A (en) * | 2011-01-30 | 2011-07-27 | 广西大学 | Method for producing high-flowability pregelatinized starch |
| CN108148144A (en) * | 2016-12-02 | 2018-06-12 | 湖南尔康制药股份有限公司 | A kind of improvement of the preparation method of medicinal pregelatinized starch |
| CN107163151A (en) * | 2017-06-12 | 2017-09-15 | 安徽紫山农业科技有限公司 | One kind prepares pregelatinized starch method with sweet potato starch |
Non-Patent Citations (1)
| Title |
|---|
| "柠檬酸对淀粉糊化性质的影响";赵前程等;《农业科技与装备》;20071220(第6期);第53-55页 * |
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